The effects of Immunoglobulin M (IgM) enriched immunoglobulin preparations in patients with severe sepsis
| ISRCTN | ISRCTN28863830 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28863830 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/04/2002
- Registration date
- 29/04/2002
- Last edited
- 07/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simru Tugrul
Scientific
Scientific
IU Istanbul Tip Fakültesi Anesteziyoloji AD
Cerrahi Monoblok
Çapa
Istanbul
34390 Fatih
Türkiye
| Phone | +90 (9)212 6318767 |
|---|---|
| mtugrul@isbank.net.tr |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Severe sepsis |
| Intervention | Patients in the study group (n = 21) received intravenous immunoglobulin preparation (Pentaglobin®) in addition to standard therapy. Pentaglobin® was started on the day of diagnosis of severe sepsis. 5 mL/kg/day Pentaglobin® (38 g/L IgG, 6 g/L IgM and 6 g/L IgA) was infused over 6 hours and repeated for three consecutive days. Patients in the control group (n = 18) received standard sepsis therapy, but no immunoglobulin administration. Blood samples for procalcitonin measurements were taken daily for eight days. Severity of critical illness and development of organ failures were assessed by obtaining daily Acute Physiological and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pentaglobin® |
| Primary outcome measure | Procalcitonin (PCT) measurements; blood samples were taken daily for eight days following study admission. |
| Secondary outcome measures | 1. Severity of critical illness, assessed by obtaining daily acute physiological and chronic health evaluation score (APACHE II) 2. Sequential organ failure assessment (SOFA) score used to assess the development of organ failure 3. Duration of mechanical ventilation 4. Length of stay in the intensive care unit 5. Septic shock incidence 6. 28-day mortality rate |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 39 |
| Key inclusion criteria | Thirty-nine patients with severe sepsis, defined as: 1. Temperature of greater than 38°C or less than 36°C 2. Heart rate of greater than 90 beats/min 3. Respiratory rate greater than 20/min or arterial carbon dioxide pressure (PaCO2) less than 32 mmHg 4. White blood cell count greater than 12000/mm^3 or less than 4000/mm^3 5. Documented infection and dysfunction of an organ or hypotension |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
IU Istanbul Tip Fakültesi Anesteziyoloji AD
Istanbul
34390 Fatih
Türkiye
34390 Fatih
Türkiye
Sponsor information
Istanbul University (Turkey)
Hospital/treatment centre
Hospital/treatment centre
Anesthesiology Department
Istanbul Medical Faculty
Istanbul
-
Türkiye
| Website | http://www.istanbul.edu.tr/english/ |
|---|---|
"ROR" |
https://ror.org/03a5qrr21 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2002 | Yes | No |
